510(k) K821736
K821736 is an FDA 510(k) premarket notification submitted by Rabar, Inc. for the device "ECHO-PULSE KM555". The FDA issued a decision of Substantially Equivalent on December 9, 1982. The device falls under product code GXW (Echoencephalograph), a Class II device regulated under 21 CFR 882.1240. Rabar, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1982
- Date Received
- June 14, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Echoencephalograph
- Device Class
- Class II
- Regulation Number
- 882.1240
- Review Panel
- NE
- Submission Type